Z-1970-2020Class II

SureStep Foley Tray System -

Name: Z-1970-2020 SureStep Foley Tray System -
Creator: C.R. Bard Inc
Published: 2020-04-15
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2020-04-15 / Terminated

FDA source

C.R. Bard Inc began a recall of SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished... on 2020-04-15. FDA classified it as Class II and gives the reason as "There is potential for a white paper-type residue attached to the catheter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1970-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-15
Posted: 2020-05-13
Terminated: 2021-05-20
Recalling firm: C.R. Bard Inc
Product: SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: There is potential for a white paper-type residue attached to the catheter.
FDA root cause: Under Investigation by firm
Action: Customer/Distributer letters were mailed on April 27, 2020 via FedEx and email. BD will request distributors to conduct a sub-recall on BDs behalf. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers and distributors discard affected unit(s). Any unit(s) that are returned to BD will be quarantined upon arrival and discarded per procedure.
Quantity in commerce: 8392 units
Distribution: US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.
Product codes and lots: Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGDW1548 (Exp. 11/30/2021); NGDW0234 (Exp. 11/30/2021); NGDX4088 (Exp. 11/30/2021); NGDX4704 (Exp. 11/30/2021); NGDY0568 (Exp. 11/30/2021)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1970-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1970-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-13

Product code MJC

K040658Class IIBardex I.c. Latex Foley CatheterC.R. Bard, Inc. / cleared 2004-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)